Monthly medicines update
Summary of new marketing authorisations and changes to existing authorisations that relate to the safe use of the product
A rolling 6 month summary with the most recent one first.
Our Product Information Database (PID) is your primary resource for the most current information about all veterinary medicines authorised in Great Britain and Northern Ireland. As product details change we update the Summary of Product Characteristics (SPC) and label text there. Please note there may be a delay before formal documentation is available for some Northern Ireland products.
It may take up to 12 months for changes to appear on marketed packaging.
Products are authorised separately in Great Britain and Northern Ireland although authorisations may be aligned if they are the same product held by the same authorisation holder. This may mean that products are authorised or changed on different timescales in each territory.
Also find here a list of specific Pregnancy Warnings which we update quarterly.
September 2025
Change in Distribution Category from NFA-VPS to AVM-GSL
-
Advantage 40 mg Spot-on Solution for Small Cats, Small Dogs and Pet Rabbits; Advantage 80 mg Spot-on Solution for Large Cats and Pet Rabbits
Active substance: Imidacloprid
Territory / Distribution category: AVM-GSL
Authorisation holder: Elanco Europe Ltd
-
Drontal Oral Suspension for Puppies Febantel 15 mg/ml / Pyrantel 5 mg/ml
Active substance: Febantel, Pyrantel
Territory / Distribution category: GB AVM-GSL
Authorisation holder: Vetoquinol UK Limited
Section 3.3: Do not use simultaneously with compounds containing piperazine as piperazine may block the action of pyrantel embonate contained in the product. Other worming products may contain piperazine.
Do not use simultaneously with other worming products without veterinary advice.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use during pregnancy.
Do not use in lactating bitches.
New Authorisations
-
BioEquin F Suspension for Injection for Horses
Active substance: Equine influenza virus
Territory / Distribution category: GB POM-V
Authorisation holder: Bioveta, a.s.
-
BioEquin FT Suspension for Injection for Horses
Active substance: Equine influenza virus, Clostridium tetani
Territory / Distribution category: GB POM-V
Authorisation holder: Bioveta, a.s.
-
Dicla-cocci 2.5 mg/ml Oral Suspension for Cattle and Sheep
Active substance: Diclazuril
Territory / Distribution category: GB & NI POM-VPS
Authorisation holder: Huvepharma NV
-
Xylamidor 20 mg/ml Solution for Injection for Cattle, Horses, Dogs and Cats
Active substance: Xylazine
Territory / Distribution category: GB POM-V
Authorisation holder: VetViva Richter GmbH
-
DuOtic 10 mg / 1 mg Ear Gel for Dogs
Active substance: Betamethasone acetate, Terbinafine
Territory / Distribution category: GB POM-V
Authorisation holder: Dechra Regulatory B.V.
-
Robexera 20 mg/ml Solution for Injection for Cats and Dogs
Active substance: Robenacoxib
Territory / Distribution category: GB & NI POM-V
Authorisation holder: KRKA, d.d., Novo mesto
Variations - food producing species
-
AviPro Salmonella Vac E Lyophilisate for Use in Drinking Water (Chickens)
Active substance: Salmonella enteritidis
Territory / Distribution category: UK POM-V
Authorisation holder: Elanco Europe Ltd
Change Category: Contraindications; Special warnings
Summary of change:
Section 3.5: Addition of a real time PCR method to differentiate the Salmonella vaccine strain from wild-type field isolates as an additional DIVA method.
-
AviPro Salmonella Vac T Lyophilisate for Use in Drinking Water (Chickens)
Active substance: Salmonella typhimurium
Territory / Distribution category: NI POM-V
Authorisation holder: Elanco Europe Ltd
Change Category: Target species use; contraindications, special warnings
Summary of change:
Section 3.2: Amendment of the duration of immunity for breeders and layers to 46 weeks.
Section 3.5: Addition of a real time PCR method to differentiate the Salmonella vaccine strain from wild-type field isolates as an additional DIVA method.
-
Bioestrovet Swine 0.0875 mg/ml solution for injection for pigs
Active substance: Cloprostenol
Territory / Distribution catgory: NI, POM-V
Authorisation holder: Vetoquinol UK Ltd
Change Category: Contraindications, Special warnings
Summary of change:
Section 3.3: Do not use in cases of bronchospasm or gastrointestinal dysmotility.
Section 3.4: The response of sows and gilts to induction of parturition may be influenced by the physiological state at the time of treatment. The vast majority of the animals, 95%, will commence farrowing within 36 hours of treatment. The majority of animals can be expected to respond within the period of 24+/- 5 hours following the injection, except in those cases where spontaneous parturition is imminent.
Section 3.5: To reduce the risk of anaerobic infections arising from vasoconstriction at the injection site, injections into contaminated (wet or dirty) skin areas should be avoided. Thoroughly clean and disinfect injection sites prior to administration.
Injection into adipose tissue may lead to incomplete absorption of the veterinary medicinal product.
Premature induction of farrowing will reduce the piglet`s birth weight and increase the number of stillborn piglets and non-viable and immature born piglets. It is essential that the mean length of gestation is calculated on each farm from past records and not to anticipate the term of gestation by more than two days.
Do not administer intravenously.
Section 3.7: Pregnancy: Do not administer to pregnant animals unless the objective is to terminate the pregnancy.
Fertility: There is no effect on the subsequent reproductive performance of sows treated with cloprostenol and of gilts or boars born from treated animals.
Section 3.8: In animals to which a progestogen is being administered, a decrease in the response of cloprostenol can be expected.
-
Dugnixon 50 mg/ml Solution for Injection for Cattle, Pigs and Horses
Active substance: Flunixin
Territory / Distribution catgory: GB POM-V
Authorisation holder: Global Vet Health S.L.
Change Category: Target species use; Contraindications, Special warnings
Summary of change:
Section 3.2 Indications updated:
Cattle
Adjunctive therapy in the treatment of bovine respiratory diseases, endotoxemia and acute mastitis.
Alleviation of acute inflammation and pain associated with musculoskeletal disorders.
Reduction of post-operative pain associated with dehorning in calves of less than 9 weeks.
Horses
Alleviation of acute inflammation and pain associated with musculoskeletal disorders.
Alleviation of visceral pain associated with colic.
Adjunctive therapy of endotoxemia due to or as a result of post-surgical or medical conditions or diseases that result in impaired blood circulation in the gastrointestinal tract.
Reduction of pyrexia.
Pigs
Adjunctive therapy in the treatment of swine respiratory disease.
Adjunctive treatment of postpartum dysgalactia (Mastitis-Metritis-Agalactia) syndrome in sows.
Alleviation of acute inflammation and pain associated with musculoskeletal disorders.
Reduction of post-operative pain following castration and tail docking in sucking piglets.
Section 3.3: Do not use if haematopoiesis or haemostasis is impaired.
Section 3.7:
Pregnancy: The safety of the veterinary medicinal product has been established in pregnant cows and sows. Do not use the veterinary medicinal product within 48 hours before expected parturition in cows and sows.
The safety of the veterinary medicinal product has not been established in pregnant mares. Do not use during the whole of the pregnancy.
Laboratory studies in rats have revealed fetotoxicity of flunixin after intramuscular administration at maternotoxic doses as well as an extension of the gestation period.
The veterinary medicinal product must be used within the first 36 hours postpartum only following a benefit/risk assessment performed by the responsible veterinarian and treated animals should be monitored for retained placenta.
Fertility: The safety of the veterinary medicinal product has not been established in bulls, stallions and boars intended for breeding. Do not use in breeding bulls, breeding stallions and breeding boars.
Section 3.12: Withdrawal periods changed:
Cattle
Meat and offal: 4 days (intravenous use)
31 days (intramuscular use)
Milk: 24 hours (intravenous use)
36 hours (intramuscular use)
Pigs
Meat and offal: 24 days (intramuscular use)
Horses
Meat and offal: 5 days (intravenous use)
Milk: Not authorised for use in animals producing milk for human consumption
Further extensive updates to sections 3.5 (target species and user safety warnings), 3.6 (Adverse events), 3.9 (Administration routes and dosage) and 3.10 (Symptoms of overdose). Refer to product SPC for details.
-
Euthanimal 20%, 200 mg/ml / 40%, 400 mg/ml Solution for Injection
Active substance: Pentobarbital Sodium
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Alfasan Nederland B.V.
Change Category: Target species use
Summary of change:
Addition of new target species and associated dosing information.
Original target species: pigs, goats, sheep, cattle, horses, cats and dogs
Additional new target species: rabbits, guinea pigs, mice, rats, hamsters, chickens, pigeons, ducks, small ornamental birds, snakes, turtles, lizards and frogs.
-
Moxapulvis 500 mg/g Powder for Use in Drinking Water (Chickens, Duck, Pigs, Turkeys)
Active substance: Amoxicillin
Territory / Distribution category: NI POM-V
Authorisation holder: V.M.D. n.v.
Change Category: Indications
Summary of change:
New indication in pigs: For the treatment of infections caused by Streptococcus suis.
-
Pergoquin 1 mg Tablets for Horses
Active substance: Pergolide
Territory / Distribution category: GB & NI POM-V
Authorisation holder: VetViva Richter GmbH
Change Category: Contraindications, special warnings
Summary of change:
Section 3.5: Extensive changes to user safety warnings. Refer to product SPC for details.
-
Zermex 100 mg/ml LA Solution for Injection for Cattle; Zermex 20 mg/ml LA Solution for Injection for Sheep
Active substance: Moxidectin
Territory / Distribution category: GB & NI POM-VPS
Authorisation holder: Zoetis UK Limited
Change Category: Contraindications, Special warnings
Summary of change:
Section 4.4: Resistance to moxidectin has been reported in Cooperia spp. and Ostertagia spp. in cattle. (100 mg/ml product only)
Psoroptes ovis is an extremely contagious external parasite of sheep and cattle. To ensure complete control, great care must be taken to avoid reinfestation, as mites may be viable for up to 15 days off the animal. It is important that all animals which have been in contact with infected ones are treated with an appropriate product. Contact between treated, infected and untreated herds must be avoided until at least seven days after treatment.
Resistance to moxidectin has been reported in Psoroptes ovis scab mites in sheep and in cattle. Cases of side-resistance with other macrocyclic lactones (ivermectin and doramectin) have been reported as well. The use of this product should take into account local information about susceptibility of the target parasites, where available.
Section 4.5: To prevent a possible anaphylactic type reaction, do not inject the product intravenously.’ (100 mg/ml product only)
Section 4.9 (Amounts to be administered and administration route) also updated, refer to SPC for details.
Link to GB SPC 100mg/ml Cattle
Link to NI SPC 100mg/ml Cattle
Variations - Companion animal species
-
Lotilaner Elanco 12 mg / 48 mg Chewable Tablets for Cats
Active substance: Lotilaner
Territory / Distribution category: GB POM-V
Authorisation holder: Elanco GmBH
Change Category: Adverse reactions
Summary of change:
Section 4.6: Addition of anorexia, lethargy, tachypnoea, ataxia, muscle tremor, hyperactivity and pruritus as adverse events with ‘very rare’ frequency (<1 animal / 10,000 animals treated, including isolated reports).
-
Neptra Ear Drops Solution for Dogs
Active substance: Florfenicol; Mometasone Furoate; Terbinafine hydrochloride
Territory / Distribution category: GB POM-V
Authorisation holder: Elanco Animal Health GmbH
Change Category: Adverse Reactions
Summary of change:
Section 4.6: Updated to include facial paralysis as very rare adverse reactions (<1 animal/10,000 animals treated, including isolated reports).
-
NexGard Combo Spot-on Solution for Cats <2.5 kg / 2.5-7.5 kg
Active substance: Eprinomectin; Esafoxolaner; Praziquantel
Territory / Distribution category: GB POM-V
Authorisation holder: Boehringer Ingelheim Vetmedica GmbH
Change Category: Indications
Summary of change:
Addition of new indication: Treatment of infections with eye worms (Thelazia callipaeda).
-
Simparica Trio Chewable Tablets for Dogs (Range)
Active substance: Moxidectin; Pyrantel; Sarolaner
Territory / Distribution category: GB POM-V
Authorisation holder: Zoetis UK Limited
Change Category: Target species use
Summary of change:
Section 3.2: New indication for reduction of the risk of infection with Dipylidium caninum via transmission by Ctenocephalides felis for one month after treatment. The effect is indirect due to the product’s activity against the vector.
-
Stronghold Plus 15 mg/2.5 mg spot-on solution for cats (Range)
Active substance: Sarolaner; Selamectin
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Zoetis Belgium
Change Category: Target species use
Summary of change:
Section 4.2: New indication for reduction of the risk of infection with Dipylidium caninum via transmission by Ctenocephalides felis for one month after treatment. The effect is indirect due to the product’s activity against the vector.
NI SPC available on EU Union Product Database
August 2025
New Authorisations
-
Avishield IB QX Lyophilisate for Oculonasal Suspension/use in Drinking Water for Chickens
Active substance: Avian infectious bronchitis virus
Territory / Distribution category: GB POM-V
Authorisation holder: Genera d.d.
-
Cevac Salmune ETI K Suspension for Injection for Chickens
Active substance: Salmonella enterica subsp. enterica
Territory / Distribution category: GB POM-V
Authorisation holder: Ceva Animal Health Ltd
-
Oviverm 25 mg/ml Oral Suspension for Sheep
Active substance: Praziquantel
Territory / Distribution category: NI POM-V
Authorisation holder: Bioveta, a.s.
-
Stresoron 40 mg/ml Solution for Injection for Pigs
Active substance: Azaperone
Territory / Distribution category: GB POM-V
Authorisation holder: CP Pharma Handelsgesellschaft mbH
-
Benamix 6.25 mg/g Premix for Medicated Feeding Stuff for Cats
Active substance: Benazepril
Territory / Distribution category: GB POM-V
Authorisation holder: VIRBAC
-
Elanco Ilunocitinib (4.8 mg / 6.4 mg / 8.5 mg / 15 mg) Film-coated Tablets for Dogs
Active substance: Ilunocitinib
Territory / Distribution category: GB POM-V
Authorisation holder: Elanco GmbH
-
Elanco JAK Inhibitor (4.8 mg / 6.4 mg / 8.5 mg / 15 mg) Film-Coated Tablets for Dogs
Active substance: Ilunocitinib
Territory / Distribution category: GB, POM-V
Authorisation holder: Elanco GmbH
-
Prevexto 1.25 g + 0.56 g, Medicated Collar for Cats; Prevexto 1.25 g + 0.56 g, Medicated Collar for Dogs up to 8 kg; Prevexto 4.50 g + 2.03 g, Medicated Collar for Dogs over 8 kg
Active substance: Imidacloprid; Flumethrin
Territory / Distribution category: GB NFA-VPS
Authorisation holder: VIRBAC
Link to SPC for Dogs up to 8kg
-
Zenrelia (4.8 mg / 6.4 mg / 8.5 mg / 15 mg) Film-coated Tablets for Dogs
Active substance: Ilunocitinib
Territory / Distribution category: GB POM-V
Authorisation holder: Elanco GmbH
Variations - food producing species
-
Altresyn 4 mg/ml Oral Solution for Pigs
Active substance: Altrenogest
Territory / Distribution category: GB POM-V
Authorisation holder: Ceva Animal Health Ltd
Change Category: Target species use
Summary of change:
Section 3.1 of the SPC updated from ‘weaned primiparous sows’ to ‘sows’.
-
Dimazon 50 mg/ml Solution for Injection (Cattle, Horses, Cats and Dogs)
Active substance: Furosemide
Territory / Distribution category: UK POM-V
Authorisation holder: Intervet International B.V.
Change Category:
Summary of change:
Section 3.6 of the SPC has been updated to include haemoconcentration, circulatory impairment, hypokalaemia and hyponatraemia as very rare adverse events (<1 animal/10,000 animals treated, including isolated reports).
For dogs, section 3.6 of the SPC has also been updated to include vomiting and staggering as very rare adverse events (<1 animal/10,000 animals treated, including isolated reports).
-
DIVENCE IBR MARKER LIVE Lyophilisate and Solvent for Emulsion for Injection (Cattle)
Active substance: Infectious bovine rhinotracheitis virus
Territory / Distribution catgory: GB POM-V
Authorisation holder: Laboratorios Hipra SA
Change category:
Summary of change:
Section 3.9 of the SPC updated to include a reference to the temperature (15 °C – 25 °C) of the vaccine before administration.
-
Elivec 5 mg/ml Pour-on Solution for Cattle, Sheep and Goats
Active substance: Eprinomectin
Territory / Distribution category: NI POM-VPS
Authorisation holder: Livisto Int'l, S.L.
Change Category: Target Species Use
Summary of change:
Section 3.1 of the SPC updated to include two new target species (sheep and goats). It should also be noted that there are significant updates to sections 3.2, 3.3, 3.4 3.5, 3.6, 3.7, 3.9, 3.10, 3.12 and 4.3 of the SPC.
Variations - Companion animal species
-
Bravecto (112.5 mg / 250 mg / 500 mg / 1,000 mg / 1,400 mg) Chewable Tablets for Dogs
Active substance: Fluralaner
Territory / Distribution category: GB POM-V
Authorisation holder: MSD Animal Health UK Limited
Change Category: Adverse events
Summary of change:
Section 4.6 updated to include pruritus as a very rare adverse reaction (<1 animal/10,000 animals treated, including isolated reports).
-
Bravecto (112.5 mg / 250 mg / 500 mg) Spot-on Solution for Cats
Active substance: Fluralaner
Territory / Distribution category: GB POM-V
Authorisation holder: MSD Animal Health UK Limited
Change Category: Adverse Reactions
Summary of change:
Section 4.6 updated to include pruritus and ataxia as very rare adverse reactions (<1 animal/10,000 animals treated, including isolated reports).
-
Bravecto (112.5 mg / 250 mg / 500 mg / 1,000 mg / 1,400 mg) Spot-on Solution for Dogs
Active substance: Fluralaner
Territory / Distribution category: GB POM-V
Authorisation holder: MSD Animal Health UK Limited
Change Category: Adverse Reactions
Summary of change:
Section 4.6 updated to include diarrhoea and pruritus as very rare adverse reactions (<1 animal/10,000 animals treated, including isolated reports).
-
Canixin DHPPi Lyophilisate and Solvent for Suspension for Injection for Dogs
Active substance: Canine adenovirus, Canine distemper virus, Canine parainfluenza virus, Canine parvovirus
Territory / Distribution category: NI POM-V
Authorisation holder: Virbac
Change Category: Target species use; Contraindications, Special Warnings
Summary of change:
Sections 3.4 and 3.9 of the SPC updated to include a possible vaccination of dogs from 6 weeks of age, when an early protection is recommended (in susceptible puppies).
-
Cazitel Plus Tablets for Dogs
Active substance: Febantel, Praziquantel, Pyrantel
Territory / Distribution category: GB NFA-VPS
Authorisation holder: Chanelle Pharmaceuticals Manufacturing Ltd
Change Category: Adverse events
Summary of change:
Section 3.6 of the SPC updated to include lethargy, anorexia and hyperactivity as very rare adverse reactions.
-
Dronspot (30 mg/7.5 mg / 60 mg/15 mg / 96 mg/24 mg) Spot-on Solution for Cats
Active substance: Emodepside, Praziquantel
Territory / Distribution category: NI NFA-VPS
Authorisation holder: Vetoquinol UK Limited
Change Category: Adverse events
Summary of change:
Section 4.6 of the SPC has been updated to include diarrhoea as a very rare adverse reaction (<1 animal/10,000 animals treated, including isolated reports). Additionally, the following statement has been added: ‘In very rare occasions, behavioural disorders, such as hyperactivity, anxiety and vocalisation may occur. Anorexia and lethargy have been reported in very rare occasions.
-
Easimax Plus Tablets for Dogs
Active substance: Febantel, Praziquantel, Pyrantel
Territory / Distribution category: GB NFA-VPS
Authorisation holder: Chanelle Pharmaceuticals Manufacturing Ltd
Change Category: Adverse events
Summary of change:
Section 4.6 of the SPC updated to include lethargy, anorexia and hyperactivity as very rare adverse reactions (<1 animal/10,000 animals treated, including isolated reports).
-
Eluracat 20 mg/ml Oral Solution for Cats
Active substance: Capromorelin tartrate
Territory / Distribution category: NI POM-V
Authorisation holder: Elanco GmbH
Change Category: Adverse events
Summary of change:
Section 3.6 of the SPC has been updated to include anorexia and behaviour disorders as rare adverse events and dyspnoea, loss of consciousness, sedation, recumbency, muscle weakness and hiding as very rare adverse events (<1 animal/10,000 animals treated, including isolated reports).
SPC available from EU Union Product Database
-
Neptra [Dogs]
Active substance: Florfenicol, Mometasone Furoate, Terbinafine hydrochloride
Territory / Distribution category: NI POM-V
Authorisation holder: Elanco Animal Health GmbH
Change Category: Adverse Reactions
Summary of change:
Section 3.6 of the SPC has been updated to include facial paralysis as a very rare adverse event.
SPC available from EU Union Product Database
-
NexGard (11 mg / 28 mg / 68 mg / 136 mg) Chewable Tablets for Dogs
Active substance: Afoxolaner
Territory / Distribution category: NI POM-V
Authorisation holder: Boehringer Ingelheim Vetmedica Gmbh
Change Category: Target Species use
Summary of change:
Section 3.2 updated with the following information: ‘For reduction of the risk of infection with Babesia canis via transmission by Dermacentor reticulatus for 28 days. For reduction of the risk of infection with Dipylidium caninum via transmission by Ctenocephalides felis for 30 days. The effects are indirect due to the activity of the veterinary medicinal product against the vector’
SPCs available from Union Product Database
-
Prazitel Plus XL Tablets for Dogs
Active substance:
Febantel
Praziquantel
Pyrantel Embonate
Territory / Distribution category: GB NFA-VPS
Authorisation holder: Chanelle Pharmaceuticals Manufacturing Ltd
Change Category: Adverse Reactions
Summary of change:
Section 4.6 of the SPC updated to include lethargy, anorexia and hyperactivity as very rare adverse reactions.
-
Profender (15 mg/3 mg / 50 mg/10 mg / 150 mg/30 mg) Modified-Release Tablets for Dogs; Profender Spot-on Solution for (Small / Medium / Large) Cats
Active substance: Emodepside, Praziquantel
Territory / Distribution category: NI NFA-VPS
Authorisation holder: Vetoquinol UK Limited
Change Category: Adverse events
Summary of change:
Section 4.6 of the SPC has been updated to include diarrhoea as a very rare adverse reaction (<1 animal/10,000 animals treated, including isolated reports). Additionally, the following statement has been added: ‘In very rare occasions, behavioural disorders, such as hyperactivity, anxiety and vocalisation may occur. Anorexia and lethargy have been reported in very rare occasions.’
SPCs available from Union Product Database
-
Strantel Plus XL Tablets for Dogs
Active substance: Febantel, Praziquantel,
Pyrantel Embonate
Territory / Distribution category: GB NFA-VPS
Authorisation holder: Chanelle Pharmaceuticals Manufacturing Ltd
Change Category: Adverse events
Summary of change:
Section 4.6 of the SPC has been updated to include lethargy, anorexia and hyperactivity as very rare adverse reactions (<1 animal/10,000 animals treated, including isolated reports).
July 2025
New Authorisations
-
BioEquin F Suspension for Injection for Horses
Active substance: Equine influenza virus
Territory / Distribution category: NI POM-V
Authorisation holder: Bioveta, a.s.
-
BioEquin FT Suspension for Injection for Horses
Active substance: Clostridium tetani, Equine influenza virus
Territory / Distribution category: NI POM-V
Authorisation holder: Bioveta, a.s. Limited
-
Nobilis Multriva Gm+REOm Emulsion for Injection for Chickens
Active substance: Infectious bursal disease virus; Avian reovirus
Territory / Distribution category: NI POM-V
Authorisation holder: Intervet International B.V.
SPC Available from EU Union Product Database
-
Nobilis Multriva IBm+ND+Gm+REOm+EDS Emulsion for Injection for Chickens
Active substance: Newcastle disease virus, Infectious bursal disease virus, Avian reovirus, Egg drop syndrome virus
Territory / Distribution category: NI POM-V
Authorisation holder: Intervet International B.V.
SPC available on the EU Union Product Database
-
Sulfequine 333 mg/g + 67 mg/g Oral Paste for Horses
Active substance: Sulfadiazine, Trimethoprim
Territory / Distribution category: NI POM-V
Authorisation holder: CP Pharma Handelsgesellschaft mbH
-
Ventimaxx 25 Microgram/ml Oral Solution for Horses
Active substance: Clenbuterol hydrochloride
Territory / Distribution category: NI POM-V
Authorisation holder: Alfasan Nederland B.V.
-
VeteCorH 1000 IU/ml Lyophilisate and Solvent for Solution for Injection for Cattle, Horses, Sheep, Goats, Pigs, Cats and Dogs
Active substance: Chorionic Gonadotrophin
Territory / Distribution category: NI, POM-V
Authorisation holder: Laboratorios Calier, S.A.
-
Daxocox 140 mg Tablets for Dogs; Daxocox 200 mg Tablets for Dogs
Active substance: Enflicoxib
Territory / Distribution category: GB, POM-V
Authorisation holder: Ecuphar NV
-
Lozenord 5 mg/ml Solution for Injection for Dogs and Cats
Active substance: Meloxicam
Territory / Distribution category: GB, POM-V
Authorisation holder: Accord Healthcare B.V
-
Meloxicam-Boehringer 0.5 mg/ml Oral Suspension for Cats and Guinea Pigs; Meloxicam-Boehringer 1.5 mg/ml Oral Suspension for Dogs
Active substance: Meloxicam
Territory / Distribution category: GB, POM-V
Authorisation holder: Boehringer Ingelheim Animal Health UK Limited
Link to SPC Cats and Guinea Pigs
-
Numelvi 4.8 mg Tablets for Dogs; Numelvi 7.2 mg Tablets for Dogs; Numelvi 21.6 mg Tablets for Dogs; Numelvi 31.6 mg Tablets for Dogs
Active substance: Atinvicitinib
Territory / Distribution category: NI, POM-V
Authorisation holder: Intervet International BV
SPCs available from EU Union Product Database
-
Omeprazole TriviumVet 10 mg Gastro-resistant Capsules for Dogs
Active substance: Omeprazole
Territory / Distribution category: NI POM-V
Authorisation holder: TriviumVet DAC
SPC available from EU Union Product Database
-
Prevexto 1.25 g + 0.56 g, Medicated Collar for Cats; Prevexto 1.25 g + 0.56 g, Medicated Collar for Dogs up to 8 kg; Prevexto 4.50 g + 2.03 g, Medicated Collar for Dogs over 8 kg
Active substance: Imidacloprid, Flumethrin
Territory / Distribution category: NI NFA-VPS
Authorisation holder: VIRBAC
Link to SPC 1.25g + 0.56g Cats
Link to SPC 1.25g + 0.56g Dogs
Link to SPC 4.50g +0.56g Dogs over 8kg
-
Zenrelia 4.8 mg Film-coated Tablets for Dogs; Zenrelia 6.4 mg Film-coated Tablets for Dogs; Zenrelia 8.5 mg Film-coated Tablets for Dogs; Zenrelia 15 mg Film-coated Tablets for Dogs
Active substance: Ilunocitinib
Territory / Distribution category: NI POM-V
Authorisation holder: Elanco GmbH
SPCs available from EU Union Product Database
Variations - food producing species
-
DIVENCE PENTA Lyophilisate and Solvent for Emulsion for Injection [Cattle]
Active substance: Bovine parainfluenza virus 3, Bovine respiratory syncytial virus,
E2 recombinant protein, Infectious bovine rhinotracheitis virus
Territory / Distribution category: NI POM-V
Authorisation holder: Laboratorios Hipra SA
Change Category: Target species use; adverse reactions
Summary of change:
Section 4.9: Clarification of the temperature of use (15 °C – 25 °C) to ensure the correct handling of the veterinary medicinal product.
Section 3.6: Addition with a frequency of uncommon adverse events related to a temporary mild reduction in milk production, feed intake and activity.
SPC available from EU Union Product Database
-
Unistrain PRRS Lyophilisate and Solvent for Suspension for Injection for Pigs
Active substance: Porcine respiratory and reproductive syndrome virus
Territory / Distribution category: NI POM-V
Authorisation holder: Laboratorios Hipra SA
Change Category: Target Species Use
Summary of change:
Sections 3.2 and 3.9: Update to reduce the minimum age of vaccination of pigs from 4 weeks to 3 weeks.
-
Vey Tosal 100 mg/ml + 0.05 mg/ml Solution for Injection for Horses, Cattle and Dogs
Active substance: Butafosfan, Cyanocobalamin
Territory / Distribution catgory: NI POM-V
Authorisation holder: Veyx-Pharma GmbH
Change category: Target Species Use
Summary of change:
Section 3.1: Removal of cats as a target species.
Section 3.2: updated indications:
All target species:
- Supportive treatment and prevention of hypophosphatemia and/or cyanocobalamin (vitamin B12) deficiency.
Cattle:
- Supportive treatment to restore rumination following surgical treatment of displaced abomasum associated with secondary ketosis.
- Complementary treatment of parturient paresis in addition to Ca/Mg therapy.
- Prevention of ketosis development, if administered before calving.
Horses:
- Adjunctive therapy in horses suffering from muscular exhaustion.
Variations - Companion animal species
-
Bravecto 112.5 mg / 250 mg / 500 mg spot-on solution for cats
Active substance: Fluralaner
Territory / Distribution category: NI POM-V
Authorisation holder: Intervet International B.V.
Change Category: Adverse Reactions
Summary of change:
Section 3.6: Addition of ataxia and pruritus with a frequency of very rare (<1 animal/10,000 animals treated, including isolated reports).
SPCs available from EU Union Product Database
-
Bravecto Chewable Tablets for Dogs [Range]; Bravecto spot-on solution for dogs [Range]
Active substance: Fluralaner
Territory / Distribution category: NI POM-V
Authorisation holder: Intervet International B.V
Change Category: Adverse Reactions
Summary of change:
Section 3.6: Addition of diarrhoea with a frequency of common (1 to 10 animals / 100 animals treated), and pruritus with a frequency of very rare (<1 animal/10,000 animals treated, including isolated reports).
SPCs available from EU Union Product Database
-
Cazitel Plus XL Tablets for Dogs
Active substance: Febantel, Praziquantel,
Pyrantel Embonate
Territory / Distribution category: NI POM-V
Authorisation holder: Laboratorios Hipra SA
Change Category: Adverse Reactions
Summary of change:
Section 3.6: Addition of lethargy, anorexia, and hyperactivity with a frequency of very rare (<1 animal/10,000 animals treated, including isolated reports).
-
Eurican DHPPi [Dogs]
Active substance: Canine adenovirus, Canine distemper virus, Canine parainfluenza virus, Canine parvovirus
Territory / Distribution category: UK POM-V
Authorisation holder: Boehringer Ingelheim Animal Health UK Limited
Change Category: Interactions and Overdose
Summary of change:
Section 4.8: To add the compatibility claim for Eurican DHPPi with Eurican L4.
-
NexGard Combo spot-on solution for cats <2.5 kg; NexGard Combo spot-on solution for cats 2.5-7.5 kg
Active substance: Eprinomectin, Esafoxolaner, Praziquantel
Territory / Distribution category: NI POM-V
Authorisation holder: Boehringer Ingelheim Vetmedica GmbH
Change Category: Target Species Use
Summary of change:
Section 3.2: Addition of a new indication: for the treatment of infections with eye worms (Thelazia callipaeda).
Modification of an indication for immediate tick killing activity against Ixodes hexagonus
Corresponding changes have been made to sections 3.4, 3.9, and 4.3 of the SPCs.
SPCs available from EU Union Product Database
-
Nexgard Spectra Chewable Tablets for Dogs [Range]
Active substance: Afoxolaner, Milbemycin Oxime (A3 and A4)
Territory / Distribution category: NI POM-V
Authorisation holder: Boehringer Ingelheim Vetmedica GmbH
Change Category: Target Species Use
Summary of change:
Section 3.2: Addition of two new indications:
For reduction of the risk of infection with Dipylidium caninum via transmission by Ctenocephalides felis for 30 days.
For reduction of the risk of infection with Babesia canis canis via transmission by Dermacentor reticulatus for 28 days.
The effects are indirect due to the activity of the veterinary medicinal product against the vectors.
Corresponding changes have been made to sections 3.4, 3.9, and 4.3 of the SPCs.
SPC available from EU Union Product Database
-
Nobivac L4 Suspension for Injection for Dogs
Active substance: Leptospira australis, Leptospira canicola, Leptospira grippotyphosa, Leptospira icterohaemorrhagiae
Territory / Distribution category: NI POM-V
Authorisation holder: Intervet International B.V.
Change Category: Target Species Use; Interactions and Overdose
Summary of change:
Section 3.2: Addition of a new therapeutic indication for 2 new Leptospira serovars, and existing Leptospira serovars.
Section 3.8: Addition of associated non-mixed use with Nobivac Rabies vaccine.
SPC available from EU Union Product Database
-
Nobivac LoVo L4 Suspension for Injection for Dogs
Active substance: Leptospira interrogans serogroup Australis, Leptospira interrogans serogroup Canicola, Leptospira interrogans serogroup Icterohaemorrhagiae, Leptospira kirschneri serogroup Grippotyphosa
Territory / Distribution category: NI POM-V
Authorisation holder: Intervet International B.V.
Change Category: Target Species Use; Interactions and Overdose
Summary of change:
Section 3.2: Addition of a new therapeutic indication for 2 new Leptospira serovars, and existing Leptospira serovars.
Section 3.8: Addition of associated non-mixed use with Nobivac Rabies vaccine.
SPC available from EU Union Product Database
-
Prazitel Plus Tablets for Dogs
Active substance: Febantel, Praziquantel, Pyrantel
Territory / Distribution category: GB NFA-VPS
Authorisation holder: Chanelle Pharmaceuticals Manufacturing Ltd
Change Category: Adverse Reactions
Summary of change:
Section 3.6: Addition of lethargy, anorexia, and hyperactivity with a frequency of very rare (<1 animal/10,000 animals treated, including isolated reports).
-
Quantilex Plus XL Tablets for Dogs
Active substance: Febantel, Praziquantel, Pyrantel Embonate
Territory / Distribution category: GB NFA-VPS
Authorisation holder: Chanelle Pharmaceuticals Manufacturing Ltd
Change Category: Adverse Reactions
Summary of change:
Section 3.6: Addition of lethargy, anorexia, and hyperactivity with a frequency of very rare (<1 animal/10,000 animals treated, including isolated reports).
-
Seresto Flea and Tick Control 1.25 g + 0.56 g, Collar for Cats; Seresto Flea and Tick Control 1.25 g + 0.56 g, Collar for Small Dogs ≤ 8 kg; Seresto Flea and Tick Control 4.50 g + 2.03 g, Collar for Large Dogs > 8 kg
Active substance: Flumethrin, Imidacloprid
Territory / Distribution category: UK NFA-VPS
Authorisation holder: Elanco Europe Ltd
Change Category: Adverse Reactions
Summary of change:
Section 3.6: Addition of application site reaction (haemorrhage and scratching), behavioural disorder (vocalisation) and lethargy with a frequency of rare (1 to 10 animals / 10000 animals treated).
-
Simparica Trio Chewable Tablets for Dogs [Range]
Active substance: Moxidectin, Pyrantel, Sarolaner
Territory / Distribution category: GB POM-V
Authorisation holder: Zoetis UK Limited
Change Category: Target Species Use
Summary of change:
Section 3.2: Added for the treatment of Angiostrongylus vasorum.
Section 3.9: Treatment of angiostrongylosis (caused by Angiostrongylus vasorum):
A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment. A further assessment should then be carried out following the second treatment. Continued monitoring should be performed as appropriate for each case.
-
Vey Tosal 100 mg/ml + 0.05 mg/ml Solution for Injection for Horses, Cattle and Dogs
Active substance: Butafosfan
Cyanocobalamin
Territory / Distribution category: NI POM-V
Authorisation holder: Veyx-Pharma GmbH
Change Category: Target Species Use
Summary of change:
Section 3.1: Removal of cats as a target species.
Section 3.2: updated indications for all target species: Supportive treatment and prevention of hypophosphatemia and/or cyanocobalamin (vitamin B12) deficiency.
June 2025
New Authorisations
-
Avishield IB QX Lyophilisate for Oculonasal Suspension/use in Drinking Water for Chickens
Active substance: Avian infectious bronchitis virus
Territory / Distribution category: NI POM-V
Authorisation holder: Genera Inc.
-
Innovax-ND-H5 Concentrate and Solvent for Suspension for Injection for Chickens
Active substance: Turkey herpesvirus
Territory / Distribution category: GB POM-V
Authorisation holder: MSD Animal Health UK Limited
-
Lincoral-S 222 mg/g + 444.7 mg/g Powder for Use in Drinking Water for Pigs and Chickens
Active substance: Lincomycin Hydrochloride, Spectinomycin Sulphate
Territory / Distribution category: GB POM-V
Authorisation holder: Huvepharma NV
-
Nobilis Multriva IBm+ND
Active substance: Infectious bronchitis virus, Infectious bronchitis virus, Newcastle disease virus
Territory / Distribution category: NI POM-V
Authorisation holder: Intervet International B.V.
SPC available on the EU Union Product Database
-
Ovimel 18 mg Implantation Tablets for Sheep
Active substance: Melatonin
Territory / Distribution category: GB & NI POM-VPS
Authorisation holder: Vetpharma Animal Health, S.L
-
Syvazul BTV 3 Suspension for Injection for Sheep and Cattle
Active substance: Bluetongue virus
Territory / Distribution category: GB POM-V
Authorisation holder: Laboratorios SYVA S.A.U
-
Vectormune HVT-AIV Concentrate and Solvent for Suspension for Injection for Chickens
Active substance: Cell-associated live recombinant turkey herpesvirus
Territory / Distribution category: GB, POM-V
Authorisation holder: Ceva Animal Health Ltd
-
Beaphar WORMclear PLUS 30 mg/7.5 mg Spot-on Solution for Small Cats; Beaphar WORMclear PLUS 60 mg/15 mg Spot-on Solution for Medium Cats; Beaphar WORMclear PLUS 96 mg/24 mg Spot-on Solution for Large Cats
Active substance: Praziquantel, Emodepside
Territory / Distribution category: GB, POM-V
Authorisation holder: KRKA, d.d., Novo mesto
-
Daxocox 140 mg Tablets for Dogs; Daxocox 200 mg Tablets for Dogs
Active substance: Enflicoxib
Territory / Distribution category: GB, POM-V
Authorisation holder: Ecuphar NV
-
Elmaro 10 mg/ml Solution for Injection for Dogs and Cats
Active substance: Maropitant
Territory / Distribution category: GB, POM-V
Authorisation holder: Elanco GmbH
-
Meloxicam-Boehringer 0.5 mg/ml Oral Suspension for Cats and Guinea Pigs; Meloxicam-Boehringer 1.5 mg/ml Oral Suspension for Dogs
Active substance: Meloxicam
Territory / Distribution category: GB, POM-V
Authorisation holder: Boehringer Ingelheim Animal Health UK Limited
Link to SPC Cats and Guinea Pigs
-
Novospot Worming Solution 30 mg/7.5 mg Spot-on Solution for Small Cats; Novospot Worming Solution 60 mg/15 mg Spot-on Solution for Medium Cats; Novospot Worming Solution 96 mg/24 mg Spot-on Solution for Large Cats
Active substance: Praziquantel, Emodepside
Territory / Distribution category: GB, POM-V
Authorisation holder: KRKA, d.d., Novo mesto
-
Pet Shield Worm Screen 30 mg/7.5 mg Spot-on Solution for Small Cats; Pet Shield Worm Screen 60 mg/15 mg Spot-on Solution for Medium Cats; Pet Shield Worm Screen 96 mg/24 mg Spot-on Solution for Large Cats
Active substance: Praziquantel, Emodepside
Territory / Distribution category: GB, POM-V
Authorisation holder: KRKA, d.d., Novo mesto
Variations - food producing species
-
Bovilis Rotavec Corona Emulsion for Injection for Cattle
Active substance: Bovine coronavirus, Bovine rotavirus, Escherichia coli
Territory / Distribution category: GB POM-VPS
Authorisation holder: MSD Animal Health UK Limited
Change Category: Interactions & Overdose
Summary of change:
SPC section 3.8: Updated to allow the associated non-mixed use of Bovilis Rotavec Corona and Bovilis Cryptium.
SPC section 3.9: Added subcutaneous route of administration.
-
Porcilis PRRS Lyophilisate and Solvent for Suspension for Injection for Pigs
Active substance: Porcine respiratory and reproductive syndrome virus
Territory / Distribution category: NI POM-V
Authorisation holder: Intervet International B.V.
Change Category: Interactions & Overdose
Summary of change:
SPC section 3.8: Product information of Porcilis PRRS updated to include associated use combinations with Porcilis PCV M Hyo ID.
-
Porcilis Lawsonia ID Lyophilisate and Solvent for Emulsion for Injection for Pigs
Active substance: Lawsonia intracellularis
Territory / Distribution category: NI POM-V
Authorisation holder: Intervet International B.V.
Change category:
Summary of change:
SPC section 3.8: Product information of Porcilis Lawsonia ID updated to include associated use combinations with Porcilis PCV M Hyo ID.
-
DIVENCE PENTA Lyophilisate and Solvent for Emulsion for Injection (Cattle)
Active substance: Bovine parainfluenza virus 3, Bovine respiratory syncytial virus, E2 recombinant protein, Infectious bovine rhinotracheitis virus
Territory / Distribution category: GB POM-V
Authorisation holder: Laboratorios Hipra SA
Change Category: Adverse reactions, Target species use
Summary of change:
SPC section 3.6: A temporary mild reduction in milk production, feed intake and activity may uncommonly be observed in dairy cows mostly after the first dose (1 to 10 animals / 1,000 animals treated).
SPC section 4.9: Allow the vaccine to reach a temperature of +15 to+ 25 °C before administration.
-
DiarrVac RCE Emulsion for Injection for Cattle; Bovigen Scour Emulsion for Injection for Cattle
Active substance: Bovine coronavirus, Bovine rotavirus, Escherichia coli
Territory / Distribution category: NI POM-VPS
Authorisation holder: Forte Healthcare Limited
Change Category: Target species use
Summary of change:
SPC sections 2 and 4.2: Update to indicate that the EC/17 vaccine strain stimulates an antibody response to F41, in addition to F5.
Variations - Companion animal species
-
Clavaseptin 50 mg / 62.5 mg Palatable Tablets for Dogs and Cats Clavaseptin 250 mg / 500 mg / 750 mg Palatable Tablets for Dogs
Active substance: Amoxicillin, Clavulanic Acid
Territory / Distribution category: NI POM-V
Authorisation holder: Vetoquinol UK Ltd
Change Category: Target species use
Summary of change:
SPC section 3.2:
In dogs: treatment of infections caused by bacteria susceptible to amoxicillin in combination with clavulanic acid (including beta-lactamase producing strains), in particular:
• Skin infections (including deep and superficial pyodermas, wounds, abscesses) caused by Staphylococcus spp., Streptococcus spp., and Pasteurella spp.
• Respiratory tract infections (sinusitis, rhino-tracheitis, bronchopneumonia) caused by Staphylococcus spp., and E. coli.
• Infections of the oral cavity (mucous membranes) caused by Streptococcus spp., and Pasteurella spp.
• Urinary tract infections (nephritis, cystitis) caused by E. coli, Klebsiella spp. and Proteus mirabilis.
• Digestive tract infections, especially gastroenteritis caused by E. coli.
In cats: treatment of infections caused by bacteria susceptible to amoxicillin in combination with clavulanic acid (including beta-lactamase producing strains), in particular:
• Skin infections (including deep and superficial pyodermas, wounds, abscesses) caused by Staphylococcus spp, Streptococcus spp. and Pasteurella spp.
• Respiratory tract infections (sinusitis, rhino-tracheitis, bronchopneumonia) caused by Staphylococcus spp. and E. coli.
• Infections of the oral cavity (mucous membranes) caused by Streptococcus spp., and Pasteurella spp.
• Urinary tract infections (nephritis, cystitis) caused by E. coli, Pasteurella spp., Klebsiella spp. and Proteus mirabilis.
• Digestive tract infections, especially gastroenteritis caused by E. coli.
Link to SPC 50mg dogs and cats
Link to SPC 62.5mg dogs and cats
-
Credelio 12 mg Chewable Tablets for Cats (0.5–2.0 kg); Credelio 48 mg Chewable Tablets for Cats (>2.0–8.0kg)
Active substance: Lotilaner
Territory / Distribution category: GB POM-V
Authorisation holder: Elanco GmbH
Change Category: Adverse reactions
Summary of change:
SPC section 3.6: Added the adverse events anorexia, lethargy, tachypnoea, ataxia, muscle tremor, hyperactivity and pruritus with a frequency of very rare (<1 animal/10,000 animals treated, including isolated reports).
-
Simparica Trio Chewable Tablets for Dogs (Range)
Active substance: Moxidectin, Pyrantel, Sarolaner
Territory / Distribution category: NI POM-V
Authorisation holder: Zoetis Belgium
Change Category: Target species use
Summary of change:
SPC section 3.2: Addition of indication for the treatment of angiostrongylosis (Angiostrongylus vasorum) and associated dosing advice.
SPCs available from EU Union Product Database
May 2025
New Authorisations
-
Icthiovac Erm Concentrate for dip suspension for Atlantic salmon
Active substance: Yersinia ruckeri
Territory / Distribution category: NI POM-V
Authorisation holder: Laboratorios Hipra SA
SPC available from EU Union Product Database
-
Nobilis Multriva IBm+ND+EDS Emulsion for Injection for Chickens
Active substance: Infectious bronchitis virus, Newcastle disease virus, Egg drop syndrome virus
Territory / Distribution category: NI POM-V
Authorisation holder: Intervet International BV
SPC available from EU Union Product Database
-
Poulvac Poulinac ND+IB M41+EDS Emulsion for Injection for Chickens
Active substance: Newcastle disease virus, Infectious bronchitis virus, Egg drop syndrome virus,
Territory / Distribution category: GB POM-V
Authorisation holder: Laboratorios Karizoo S.A
-
Amlodicor 1.25 mg Chewable Tablets for Cats
Active substance: Amlodipine
Territory / Distribution category: GB POM-V
Authorisation holder: Ceva Animal Health Ltd
-
Amocard 1.25 mg Chewable Tablets for Cats
Active substance: Amlodipine
Territory / Distribution category: GB POM-V
Authorisation holder: Accord Healthcare B.V
-
Prazemo Spot-On Worming Solution 30 mg/7.5 mg Spot-on Solution for Small Cats;Prazemo Spot-On Worming Solution 60 mg/15 mg Spot-on Solution for Medium Cats; Prazemo Spot-On Worming Solution 96 mg/24 mg Spot-on Solution for Large Cats
Active substance: Emodepside, Praziquantel
Territory / Distribution category: GB & NI POM-V
Authorisation holder: KRKA, d.d., Novo mesto
-
Prazendo 50 mg Tablets for Dogs
Active substance: Praziquantel
Territory / Distribution category: GB, AVM-GSL
Authorisation holder: Ashish Life Science Holding B.V.
-
Praziquantel/Emodepside Krka Worming Spot-on Solution 30 mg/7.5 mg for Small Cats; Praziquantel/Emodepside Krka Worming Spot-on Solution 60 mg/15 mg for Medium Cats; Praziquantel/Emodepside Krka Worming Spot-on Solution 96 mg/24 mg for Large Cats
Active substance: Emodepside, Praziquantel
Territory / Distribution category: GB & NI, POM-V
Authorisation holder: KRKA, d.d., Novo mesto
Variations - food producing species
-
Bovalto Respi Intranasal, Nasal Spray, Lyophilisate and Solvent for Suspension (Cattle)
Active substance: Bovine respiratory syncytial virus, Bovine parainfluenza virus 3
Territory / Distribution category: NI POM-V
Authorisation holder: Boehringer Ingelheim Animal Health UK Limited
Change Category: Indications for use
Summary of change:
Section 3.9: Addition of further information to the user regarding the reconstitution of the 10-dose presentation to avoid any misuse in the field.
-
DIVENCE IBR MARKER LIVE Lyophilisate and Solvent for Emulsion for Injection (Cattle)
Active substance: Infectious bovine rhinotracheitis virus
Territory / Distribution category: GB POM-V
Authorisation holder: Laboratorios Hipra SA
Change Category: Indications for use
Summary of change:
Section 3.9: DIVENCE IBR MARKER LIVE vaccine may be used for subsequent re-vaccinations after vaccination with DIVENCE TRI vaccine if there is no further need for protection against BRSV and PI-3, where available.
-
Nuflor 300 mg/ml Solution for Injection for Cattle and Sheep
Active substance: Florfenicol
Territory / Distribution category: GB & NI POM-V
Authorisation holder: MSD Animal Health UK Limited
Change category: Contraindications, special warning
Summary of change:
Section 5.5: The veterinary medicinal product should not enter water courses as florfenicol may be dangerous for aquatic organisms.
Variations - Companion animal species
-
Alizin 30 mg/ml Solution for Injection (Dogs)
Active substance: Aglepristone
Territory / Distribution category: NI POM-V
Authorisation holder: Virbac
Change Category: Contraindications, special warnings; Adverse reactions
Summary of change:
Section 3.5: Bitches that remain pregnant despite treatment should be monitored, as viability of the puppies may be compromised and serious complications such as dystocia and uterine rupture could result from abortion failure.
Section 3.6: Associated lack of efficacy adverse event included.
-
Ataxxa Spot-on Solution for Dogs (Range)
Active substance: Imidacloprid; Permethrin (Cis:Trans 40:60)
Territory / Distribution category: NI POM-V
Authorisation holder: KRKA, d.d., Novo mesto
Change Category: Contradications, Special warnings
Summary of change:
Section 3.5: Added for the 2000 mg/400 mg pipette size only:
The product should not be administered by pregnant women and women suspected of being pregnant. Gloves should be worn by women of childbearing age when handling the veterinary medicinal product.
Section 3.7: Added warnings regarding foetotoxic effects identified in rabbits and rats of the excipient N methyl pyrrolidone.
-
Lotilaner Elanco Chewable Tablets for Dogs (Range); Lotilaner Elanco Chewable Tablets for Cats (Range)
Active substance: Lotilaner
Territory / Distribution category: NI NFA-VPS
Authorisation holder: Elanco GmbH
Change Category: Change in distribution category
Summary of change:
Change in distribution category from POM-V to NFA-VPS with the removal of indications regarding flea allergy dermatitis (FAD) and demodicosis to reflect the change to a non prescription status.
SPCs available from EU Union Product Database
April 2025
New Authorisations
-
Bluevac-3 Suspension for Injection for Sheep and Cattle
Active substance: Bluetongue Virus
Territory / Distribution category: GB &NI POM-V
Authorisation holder: CZ Veterinaria S.A.
NI SPC available from EU Union
-
Bultavo 3 Suspension for Injection for Sheep and Cattle
Active substance: Bluetongue virus
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Boehringer Ingelheim Animal Health UK Limited
-
Diclacare 2.5 mg/ml Oral Suspension for Lambs and Calves
Active substance: Diclazuril
Territory / Distribution category: NI POM-V
Authorisation holder: Laboratorios Karizoo S.A
-
Triclacert Duo 50 mg/ml & 1 mg/ml Oral Suspension for Sheep
Active substance: Triclabendazole, Ivermectin
Territory / Distribution category: GB POM-V
Authorisation holder: EU Pharmaceuticals Ltd
-
Censutrim 200 mg/ml + 40 mg/ml Solution for Injection for Cattle, Pigs, Horses, Dogs and Cats
Active substance: Sulfadiazine, Trimethoprim
Territory / Distribution category: GB POM-V
Authorisation holder: DUGV (UK) Limited
-
Benamix 6.25 mg/g Premix for Medicated Feeding Stuff for Cats
Active substance: Benazepril
Territory / Distribution category: GB & NI POM-V
Authorisation holder: VIRBAC
-
Bravecto TriUNO Chewable Tablets for Dogs [Range]
Active substance: Fluralaner, Moxidectin, Pyrantel
Territory / Distribution category: GB & NI POM-V
Authorisation holder: MSD Animal Health UK Limited
-
Elmaro 10 mg/ml Solution for Injection for Dogs and Cats
Active substance: Maropitant
Territory / Distribution category: NI POM-V
Authorisation holder: Elanco GmbH
SPC available from EU Union Product Database
-
Ezi-Wormer Film-coated Tablets for Cats 16/40 mg (Milbemycin/Praziquantel)
Active substance: Milbemycin Oxime (A3 and A4), Praziquantel
Territory / Distribution category: GB POM-V
Authorisation holder: C&H Generics Ltd
-
Prevestrus Vet Film-Coated Tablets for Dogs [Range]
Active substance: Finrozole
Territory / Distribution category: NI POM-V
Authorisation holder: Vetcare Oy
Link to SPC 25mg
Link to SPC 50mg
Link to SPC 100mg
-
Vetmedin 1.5 mg/ml Oral Solution for Dogs
Active substance: Pimobendan
Territory / Distribution category: NI POM-V
Authorisation holder: Boehringer Ingelheim Animal Health UK Limited
-
Wormax Film-coated Tablets for Cats 16/40 mg
Active substance: Milbemycin Oxime (A3 and A4), Praziquantel
Territory / Distribution category: GB POM-V
Authorisation holder: C&H Generics Ltd
-
Wormit Film-coated Tablets for Cats 16/40 mg
Active substance: Milbemycin Oxime (A3 and A4), Praziquantel
Territory / Distribution category: GB POM-V
Authorisation holder: C&H Generics Ltd
Variations - food producing species
-
Medesedan 10 mg/ml Solution for Injection for Horses and Cattle
Active substance: Detomidine Hydrochloride
Territory / Distribution category: GB & NI POM-V
Authorisation holder: CP Pharma Handelsgesellschaft mbH
Summary of change:
Multiple extensive updates have been made in relation to the SPC sections; 3.3 Contraindications, 3.5 Special precautions for use; 3.6 Adverse events, 3.7 Fertility, use during pregnancy and lactation, 3.9 Administration in combination with other sedatives and anaesthetics and 3.10 Overdose.
-
Detogesic 10 mg/ml Solution for Injection for Horses
Active substance: Detomidine Hydrochloride
Territory / Distribution category: NI POM-V
Authorisation holder: Vetcare Limited
Summary of change:
Multiple extensive updates have been made in relation to the SPC sections; 3.2 Indications, 3.3 Contraindications, 3.5 Special precautions for use, 3.6 Adverse events, 3.7 Fertility, use during pregnancy and lactation, 3.8 Interactions with other medicinal products, 3.9 Administration routes and dosage, 3.10 Overdose and 4.2 and 4.3 Pharmacology.
-
Vigophos 100 mg / ml + 0.05 mg / ml Solution for Injection for Cattle, Horses and Dogs
Active substance: Butafosfan, Cyanocobalamin
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Livisto Int'l, S.L.
Change category: Target species
Summary of change:
The veterinary medicinal product is now authorised for use in horses for supportive treatment and prevention of hypophosphataemia and/or cyanocobalamin (vitamin B12) deficiency, and as an adjunctive therapy in horses suffering from muscular exhaustion. Extensive associated changes have been made to multiple sections of the SPC due to the addition of this new target species.
See under Companion animals listing for changes relevant for use in dogs.
-
Zermex 100 mg/ml LA Solution for Injection for Cattle
Active substance: Moxidectin
Territory / Distribution category: GB & NI POM-VPS
Authorisation holder: Zoetis UK Limited
Change category: Contraindications, Special warnings; Adverse reactions; Target species use.
Summary of change:
Sections 4.4 and 4.5 have been updated to provide further warnings and precautions to advise on safe and effective use.
Section 4.6 has been updated to indicate that on very rare occasions, hypersensitivity reactions and/or neurological disorders (such as collapse, convulsion, paralysis, and blindness) may occur. Severe reactions may be fatal.
Section 4.9 has been updated to provide further general information regarding dosing.
-
Zermex 20 mg/ml LA Solution for Injection for Sheep
Active substance: Moxidectin
Territory / Distribution category: GB & NI POM-VPS
Authorisation holder: Zoetis UK Limited
Change category: Contraindications, Special warnings; Adverse reactions;
Summary of change:
Section 4.4 has been updated to provide further warnings relating to effective use.
Section 4.6 has been updated to indicate that on very rare occasions, neurological disorders such as collapse, convulsion, and paralysis may occur. Severe reactions may be fatal.
Variations - Companion animal species
-
Osurnia Ear Gel for Dogs
Active substance: Terbinafine, Florfenicol, Betamethasone acetate
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Dechra Limited (GB) Dechra Regulatory B.V. (NI)
Change Category: Contraindications, Special warnings; Adverse reactions
Summary of change:
Information relating to the occurrence of eye disorders, despite no direct ocular contact, has been removed from section 4.5. Instead, section 4.6 has been updated to indicate that in very rare cases, eye disorders such as neurogenic keratoconjunctivitis sicca, keratoconjunctivitis sicca, corneal ulcer, blepharospasm, eye redness and ocular discharge have been reported in treated dogs. Additionally, ataxia, internal ear disorders (mainly head tilt), facial paralysis and nystagmus have been reported in very rare cases.
NI SPC Available from EU Union Product Database
-
StromEase 25 mg/ml Eye Drops, Solution for Dogs and Cats
Active substance: Acetylcysteine
Territory / Distribution category: GB & NI POM-V
Authorisation holder: DOMES PHARMA
Change Category: Adverse events
Summary of change:
Section 4.6 has been amended to clarify that irritation or inflammation of the eye and/or its adnexa have been reported in very rare cases, especially blinking of the eyelids or even closure of the eye, eye redness or conjunctival oedema, particularly in dogs.
-
Vigophos 100 mg / ml + 0.05 mg / ml Solution for Injection for Cattle, Horses and Dogs
Active substance: Acetylcysteine
Territory / Distribution category: GB & NI POM-V
Authorisation holder: DOMES PHARMA
Change Category: Target species
Summary of change:
The veterinary medicinal product is now authorised for use in dogs for supportive treatment and prevention of hypophosphataemia and/or cyanocobalamin (vitamin B12) deficiency. Extensive associated changes have been made to multiple sections of the SPC due to the addition of this new target species.